FDA Orders Studies of Inhaled Asthma Drugs

Regulators have mandated that drugmakers conduct clinical trials with a group of 53,000 patients to test the safety of approved, inhaled asthma drugs, said Reuters.

We recently wrote that new warnings for the inhaled asthma drugs Advair, Foradil, and Symbicort were just finalized by the U.S. Food & Drug Administration (FDA). Also, we previously wrote that the agency was planning on requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA sought information on the design of these studies at a public advisory committee meeting in March 2010.

The trials have been required on a controversial drug class known as long-acting beta-agonists (LABAs) used in conjunction with inhaled steroids, an asthma drug class, the FDA just announced, said Reuters. The LABAs involved in the study are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck & Co’s Dulera, and Novartis AG’s Foradil. These drugs have been a concern of the FDA for some time because they can â€œincrease the risk of severely worsening asthma symptomsâ€ and have been linked to hospitalizations and death, noted Reuters.

LABAs prevent the release of substances in the body that cause inflammation of airways in the lungs. Advair and Symbicort use a LABA with an inhaled steroid; Serevent and Foradil (made by Novartis and marketed by Merck & Co in the U.S.) only contain LABAs. These drugs are approved to treat people whose asthma isnâ€™t well controlled by other drugs including inhaled corticosteroids.

Study results are expected in 2017; the study will begin this year. Four of the trials will involve the LABAs plus a corticosteroid and will be compared with steroid use alone; patients will be 2 years of age and older, said Reuters, adding that these studies will involve 46,800 patients. The other trial of 6,200 younger patientsâ€”aged 4 to 11â€”will look at Glaxo’s Advair Diskus.

Reuters said the large study size points to the FDAâ€™s concern about the safety of these drugs and the fact that there is such a large patient base involved.

Meanwhile, the recent recommendations do not apply to the use of LABAs for COPD therapy, another approved use of the drugs. The FDA has been reviewing LABAs for the past several years, and their labels had already warned that they could increase the risk of asthma related death. In February, the FDA said it was aiming to reduce the use of the drugs, and that they should only be used in the sickest asthma patients.

The new warnings are aimed at informing both doctors and patients about how the products should ideally be used. The label warnings are effective immediately and will be online, but it was unclear how long it would take for the new cautions to be added to actual products, the FDA said

Both Glaxo and AstraZeneca had resisted the changes, which caused the FDA to order them to do so, using authority Congress granted it in a 2007 law. This marks the eighth time the agency has used its new powers, Reuters said.